Ondansetron 8 MG Oral Tablet
1 INDICATIONS AND USAGE Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: • highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . • initial and repeat courses of moderately emetogenic cancer chemotherapy. • radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are a 5-HT3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . (1) • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (1) • nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (1) • postoperative nausea and/or vomiting (1)
Sun Pharmaceutical Industries, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
ONDANSETRON Tablets
ONDANSETRON Tablets USP, 4 mg (
ONDANSETRON hydrochloride dihydrate equivalent to 4 mg of
ONDANSETRON), are white, oval, film-coated tablets engraved with “4” on one side and “NO” on another side. They are supplied as follows: NDC 63304-458-30 Bottles of 30
ONDANSETRON Tablets USP, 8 mg (
ONDANSETRON hydrochloride dihydrate equivalent to 8 mg of
ONDANSETRON), are yellow, oval, film-coated tablets engraved with “8” on one side and “NO” on the other side. They are supplied as follows: NDC 63304-459-30 Bottles of 30 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
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